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This pilot will enroll 50 HF patients (age ≥ 75 years) undergoing CRT device implantation at the hospitals of the University of Pittsburgh Medical Center, Duke University, Ohio State University, and the VA Pittsburgh Healthcare System. Patients will be randomized to CRT-P versus CRT-D and followed until study end. Rates of patient screening, enrollment, randomization, and retention as well as cost of care will be examined. The results of this pilot study will inform the design of a large pivotal non-inferiority trial and will be necessary for its success. Patients who refuse participation in the randomized pilot trial will be asked to enroll in a prospective observational cohort. Characteristics of patients who choose CRT-P vs. CRT-D will be compared and patients' level of satisfaction with their device decision will be measured.
The goal of this study is to pilot test a randomized, controlled, non-inferiority trial comparing the survival and quality of life (QOL) of older patients receiving cardiac resynchronization therapy (CRT) pacemaker (CRT-P) versus defibrillator (CRT-D) therapy. This pilot will enroll 50 HF patients (age ≥ 75 years) undergoing CRT device implantation at the hospitals of the University of Pittsburgh Medical Center, Duke University, Ohio State University, and the VA Pittsburgh Healthcare System. Patients will be randomized to CRT-P versus CRT-D and followed until study end. Rates of patient screening, enrollment, randomization, and retention as well as cost of care will be examined. The results of this pilot study will inform the design of a large pivotal non-inferiority trial and will be necessary for its success. Patients who refuse participation in the randomized pilot trial will be enrolled and followed as part of a prospective observational cohort. Characteristics of patients who choose CRT-P vs. CRT-D will be compared and patients' level of satisfaction with their device decision will be measured.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Randomized- Pacemaker (CRT-P) | Other | Cardiac resynchronization therapy Pacemaker |
|
| Randomized- Defibrillator (CRT-D) | Other | Cardiac resynchronization therapy Defibrillator |
|
| Observational- Pacemaker (CRT-P) | Other | Cardiac resynchronization therapy Pacemaker (CRT-P): Patients in this arm declined randomization in the trial and elected to participate in the observational registry |
|
| Observational- Defibrillator (CRT-D) | Other | Cardiac resynchronization therapy Defibrillator (CRT-D): Patients in this arm declined randomization in the trial and elected to participate in the observational registry |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiac Resynchronization Therapy Pacemaker | Device | Patients randomized to the pacemaker arm will receive a CRT-P device. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Enrollment | Rates of enrollment of participants in this randomized trial | At 1 year after start of the study |
| Measure | Description | Time Frame |
|---|---|---|
| QOL | Quality of life of CRT-P versus CRT-D recipients using Minnesota Living with Heart Failure Questionnaires. The Minnesota Living with Heart Failure scale ranges from 0 to 105, in which a lower score indicates a better outcome. The Minnesota Living with Heart Failure Physical subscale ranges from 0 to 40 and the Minnesota Living with Heart Failure Mental subscale ranges from 0 to 25. Lower scores on the subscales indicate a better outcome. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Samir Saba, MD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Health System | Durham | North Carolina | 27710 | United States | ||
| The Ohio State University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36350362 | Derived | Dhande M, Myaskovsky L, Althouse A, Singh M, Weiss R, Shalaby A, Al-Khatib SM, Topoll A, Jain S, Saba S. Quality of Life and Type of Cardiac Resynchronization Therapy Device in Older Heart Failure Patients. J Palliat Med. 2023 Apr;26(4):481-488. doi: 10.1089/jpm.2022.0217. Epub 2022 Nov 8. | |
| 35357219 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | Randomized- Pacemaker (CRT-P) | Patients assigned to the pacemaker arm will receive CRT-P device |
| FG001 | Randomized- Defibrillator (CRT-D) | Patients assigned to the defibrillator arm will receive CRT-D device |
| FG002 | Observational- Pacemaker (CRT-P) | Patients in observational arm that chose CRT-P device |
| FG003 | Observational- Defibrillator (CRT-D) | Patients in observational arm that chose CRT-D device |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Randomized- Pacemaker (CRT-P) | Patients assigned to the pacemaker arm will receive CRT-P device |
| BG001 | Randomized- Defibrillator (CRT-D) | Patients assigned to the defibrillator arm will receive CRT-D device |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Enrollment | Rates of enrollment of participants in this randomized trial | Participants Enrolled | Posted | Count of Participants | Participants | At 1 year after start of the study |
|
Up to 24 months.
Adverse events were collected and classified as serious or not serious, cardiac or not cardiac. Cardiac events were further differentiated by arrhythmic or non-arrhythmic. Adverse events were not classified by specific organ system.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Randomized- Pacemaker (CRT-P) | Patients assigned to the pacemaker arm will receive CRT-P device. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eric Pasquantonio | UPMC Presbyterian Hospital | 4126478210 | pasquantonioej@upmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 24, 2018 | Jul 22, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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Randomized, open-label, controlled trial of CRT-P vs. CRT-D in HF patients (age ≥ 75 years)
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|
| Cardiac Resynchronization Therapy Defibrillator | Device | Patients randomized to the defibrillator arm will receive a CRT-D device. |
|
|
| At 6 months after enrollment |
| QOL2 | QOL of CRT-P versus CRT-D recipients using RAND-36. The RAND-36 is a normalized scale with a range of 0 to 100, in which a higher score is indicative of a better outcome. PCS-T and MCS-T are the two summary components of the RAND-36. The subscales PCS-T and MCS-T are both normalized with a range of 0 to 100. Higher scores on the subscales indicate a better outcome. | At 6 months after enrollment |
| Retention | Rates of retention of participants in this randomized trial | At 6 months after enrollment |
| Health Care Cost | Cost of health care between CRT-P and CRT-D recipients. | At 6 months after enrollment |
| Columbus |
| Ohio |
| 43210 |
| United States |
| UPMC Hamot | Erie | Pennsylvania | 16550 | United States |
| UPMC | Pittsburgh | Pennsylvania | 15213 | United States |
| Veterans Research Foundation of Pittsburgh | Pittsburgh | Pennsylvania | 15240 | United States |
| UPMC Pinnacle | Wormleysburg | Pennsylvania | 17043 | United States |
| Althouse AD, Jain SK, Shalaby A, Singh M, Weiss R, Myaskovsky L, Al-Khatib SM, Saba S. Feasibility of a Randomized Clinical Trial of Cardiac Resynchronization Therapy With or Without an Implantable Defibrillator in Older Patients. Circ Arrhythm Electrophysiol. 2022 Apr;15(4):e010795. doi: 10.1161/CIRCEP.121.010795. Epub 2022 Mar 31. No abstract available. |
| Lost to Follow-up |
|
| BG002 | Observational- Pacemaker (CRT-P) | Patients in observational arm that chose CRT-P device |
| BG003 | Observational- Defibrillator (CRT-D) | Patients in observational arm that chose CRT-D device |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Patients in observational arm that chose CRT-P device |
| OG003 | Observational- Defibrillator (CRT-D) | Patients in observational arm that chose CRT-D device |
|
|
| Secondary | QOL | Quality of life of CRT-P versus CRT-D recipients using Minnesota Living with Heart Failure Questionnaires. The Minnesota Living with Heart Failure scale ranges from 0 to 105, in which a lower score indicates a better outcome. The Minnesota Living with Heart Failure Physical subscale ranges from 0 to 40 and the Minnesota Living with Heart Failure Mental subscale ranges from 0 to 25. Lower scores on the subscales indicate a better outcome. | Only participants with complete 6-month data for QoL assessments were reported. | Posted | Mean | Standard Deviation | score on a scale | At 6 months after enrollment |
|
|
|
| Secondary | QOL2 | QOL of CRT-P versus CRT-D recipients using RAND-36. The RAND-36 is a normalized scale with a range of 0 to 100, in which a higher score is indicative of a better outcome. PCS-T and MCS-T are the two summary components of the RAND-36. The subscales PCS-T and MCS-T are both normalized with a range of 0 to 100. Higher scores on the subscales indicate a better outcome. | Only participants with complete 6-month data for QoL assessments were reported. | Posted | Mean | Standard Deviation | score on a scale | At 6 months after enrollment |
|
|
|
| Secondary | Retention | Rates of retention of participants in this randomized trial | Posted | Count of Participants | Participants | At 6 months after enrollment |
|
|
|
| Secondary | Health Care Cost | Cost of health care between CRT-P and CRT-D recipients. | Data was not collected | Posted | At 6 months after enrollment |
|
|
| 3 |
| 22 |
| 6 |
| 22 |
| 9 |
| 22 |
| EG001 | Randomized- Defibrillator (CRT-D) | Patients assigned to the defibrillator arm will receive CRT-D device | 3 | 20 | 3 | 20 | 6 | 20 |
| EG002 | Observational- Pacemaker (CRT-P) | Patients in observational arm that chose CRT-P device | 6 | 18 | 9 | 18 | 2 | 18 |
| EG003 | Observational- Defibrillator (CRT-D) | Patients in observational arm that chose CRT-D device | 17 | 42 | 18 | 42 | 13 | 42 |
| Non-Cardiac | General disorders | Systematic Assessment |
|
| Non-Cardiac | General disorders | Systematic Assessment |
|
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| Physical QOL |
|
| Emotional QOL |
|
| Rand-36: MCS-T |
|